The U.S. Food and Drug Administration issued a Complete Response Letter to UCB regarding the Belgium-based company’s Biologics License Application for bimekizumab for adults with moderate to severe plaque psoriasis.
The fresh blow to Roche’s hopes in a closely watched class of cancer immunotherapies cast a long shadow across the crowded field on May 11, but the latest setback is not the end of the road for these oncology treatments, analysts say.
Development of a new cancer treatment pioneered by Roche was thrown into doubt on May 11 when the immunotherapy drug failed to slow progression of lung cancer in a second trial, hitting the Swiss pharmaceutical maker’s shares.
AstraZeneca and Daiichi Sankyo move into earlier treatment space with EnhertuApprovals, AstraZeneca, Blockbusters, Breast Cancer, Daiichi Sankyo, Expanded Indication, FDA/Regulatory, HER2-positive breast cancer, HER2-positive metastatic breast cancer, Immunotherapies, Therapeutics, Unresectable or Metastatic HER2-Positive Breast Cancer
AstraZeneca and Daiichi Sankyo’s breast cancer therapeutic Enhertu received supplemental approval from the U.S. Food and Drug Administration. Enhertu was approved for treating adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.
Checkpoint inhibitor pioneer James P. Allison, who won the 2018 Nobel Prize in Medicine, will helm a new research and innovation hub at The University of Texas MD Anderson Cancer Center that is focused on developing new immunotherapy breakthroughs in oncology.
AstraZeneca said on March 24 the company’s drug Imfinzi, along with chemoradiotherapy, failed to achieve the main goal of improving survival in patients with locally advanced cervical cancer without the disease worsening.
Hot off the heels of the company’s milestone approval for the unique checkpoint inhibitor Opdualag, Bristol Myers Squibb forged an oncology drug discovery and development deal valued at more than $1 billion with Volastra Therapeutics.
Two Melanoma Trials Fall as BMS and Nektar Report Disappointing ResultsBlockbusters, Bristol Myers Squibb, Clinical Data, Clinical Trials, Immunotherapies, Melanoma, Merck, Metastatic Melanoma, Overall Response Rate (ORR), Primary Endpoints, Progression-Free Survival (PFS), R&D, Renal Cell Carcinoma (RCC), Therapeutics
Bristol Myers Squibb and Nektar Therapeutics released disappointing news about their joint Phase III PIVOT IO-001 study evaluating a dual therapy of the immunotherapy drug bempegaldesleukin in combination with Opdivo (nivolumab) compared with Opdivo alone to treat unresectable or metastatic melanoma.
The U.S. Food and Drug Administration placed a partial clinical hold on Alpine Immune Sciences’ NEON-2 trial, which is evaluating davoceticept (ALPN-202) in combination with Merck’s immunotherapy pembrolizumab (Keytruda) in adults with cancer.
COVID-related diabetes may be temporary; racial disparities widen with Omicron infectionsBlood Sugar Levels, Cancer Therapies, Coronavirus Infections, Covid-19 Data, COVID-19 Studies, COVID-related diabetes, Diabetes, Hospitalized COVID-19 Patients, Immunotherapies, JAMA Network, Journal of Diabetes and Its Complications, Omicron (B.1.1.529) (South Africa), R&D, Racial disparities
Patients with severe COVID-19 who develop diabetes while hospitalized may have only a temporary form of the disease and their blood sugar levels may return to normal afterward, according to new findings. Additionally, new data illustrate the jumps in U.S. coronavirus infection rates caused by the Omicron variant and the heavier toll it has taken on minorities in the latest example of racial disparity in the pandemic.